Little Cigars and Cigarillos (LCC) UseNCT06413797
Little Cigar and Cigarillo Warnings for Youth
A study testing FDA warnings + Image, FDA Warnings Text-Only and Surgeon General Text-Only Warnings in people with Little Cigars and Cigarillos (LCC) Use, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study explores the effect of the little cigars and cigarillos (LCC) warnings on youth who currently use, have ever used, or are susceptible to using LCCs. This study will inform the Food and Drug Administration (FDA) implementation of LCC warnings, which can reduce LCC use and lessen tobacco health disparities… Read more about this study
- Who is it for?
- Ages 15 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Little Cigars and Cigarillos (LCC) Use
- What is being tested?
- FDA warnings + Image, FDA Warnings Text-Only and Surgeon General Text-Only Warnings
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 928 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2024to 25 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Members of the recruitment panel (we are partnering with a panel provider for the recruitment of all participants)
- Agree to provide their honest answers
- Susceptible to using LCCs, or have ever used little cigars and/or cigarillos, or currently use little cigar and/or cigarillos in the past 30 days
- Age 15 - 20 years old
- Currently living in US or US territory
- Able to complete 2 surveys that take approximately 15 minutes
Show all 9Show fewer
- Able to complete a 2-minute survey each day for 6 days
- Able to verify they are not a bot using CAPTCHA
- Able to answer a simple, random math question
Who cannot join
- Not able to verify they are not a bot using Completely Automated Public Turing test to tell Computers and Humans Apart (CAPTCHA).
- Not able to answer a simple, random math question.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comprehensive Cancer Center at University of North Carolina
Chapel Hill, North Carolina, 27514
About this study
Official title: Strengthening Little Cigar and Cigarillo Warnings to Prevent Adolescent Use
This study explores the effect of the little cigars and cigarillos (LCC) warnings on youth who currently use, have ever used, or are susceptible to using LCCs. This study will inform the Food and Drug Administration (FDA) implementation of LCC warnings, which can reduce LCC use and lessen tobacco health disparities among youth.
Read the detailed description
Cigar use exposes youth to the addictive effects of nicotine during a critical developmental period and increases the risk of multiple cancers and premature death. Recent data indicate that cigars are the second most commonly used tobacco product by youth and that past 30-day cigar use is 7.6%, which translates into 1.1 million high school students. Of the three major types of cigars-large cigars, little cigars, and cigarillos-little cigars and cigarillos (LCCs) are the most commonly used in the US, particularly among younger people. LCC use also contributes to tobacco health disparities, as Black or African American youth use cigars more frequently than other youth. In 2016, the Food and Drug Administration (FDA) deemed LCCs subject to FDA regulation, requiring six rotating text-only warning statements to be on LCC packaging. Previous research has examined the effectiveness of LCC warnings in reducing youth willingness to use LCCs.
Research from studies of cigarette warnings suggests that effective LCC warnings should employ images that illustrate negative health effects associated with use and a larger warning label prominently displayed on the pack. Among youth, health warnings on cigarette packs that contain both text statements and images are more effective and engaging than text-only warnings. However, evidence for cigarette warning labels cannot adequately inform implementation of improved LCC warnings for three reasons: 1) there is no evidence on the effectiveness of the FDA-mandated text-only LCC warnings on behavioral intentions or other outcomes among youth 2)courts have ruled that effective tobacco warnings on one type of tobacco product cannot be used to justify warnings on other types of tobacco, and 3) LCC users have different demographic and consumption profiles than cigarette users include more Black/African Americans and use LCCs on fewer days per month.
- Conditions
- Little Cigars and Cigarillos (LCC) Use
- Being tested
- FDA warnings + Image, FDA Warnings Text-Only, Surgeon General Text-Only Warnings
- Keywords
- cigarette warnings, youth, smoke cigars, nicotine addiction, cancer prevention, Black or African American youth
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDA warnings + ImageBehavioural
For six days (days 2-7) participants will be contacted and asked to complete a daily survey. As part of the survey, participants will view FDA-proposed LCC warnings with images at 30% size on a cigarillo package. Participants will be contacted each day to be invited to complete the survey for that day of the study protocol.
FDA Warnings Text-OnlyBehavioural
Participants will receive messages including images in 30% size.
Surgeon General Text-Only WarningsBehavioural
Participants will receive messages including Surgeon General Text-only Warnings.
| Study group | Role | What they receive |
|---|---|---|
| FDA warnings + Image | Experimental | Participants will receive FDA-proposed LCC warnings with images Receives: Behavioral: FDA warnings + Image |
| FDA Warnings Text-Only Warnings | Experimental | Participants will receive FDA-proposed text-only LCC warnings. Receives: Behavioral: FDA Warnings Text-Only |
| Surgeon General Text-Only Warnings | Active comparator | Participants will receive Surgeon General text-only LCC warnings. Receives: Behavioral: Surgeon General Text-Only Warnings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Willingness to Use Little Cigars Cigarillos (LCCs)
The average willingness to use score will be measured by the average of the responses to the 2 survey questions scores. Question Scoring is on a scale of 1 to 5, where 1 indicates low willingness to use LCCs, and 5 indicates a willingness to use LCCs score.
Measured: Day 8
Secondary outcomes (18)
Past 7 Days Little Cigar Use
The number of days in the past 7 days that a participant reported using little cigars, range 0-7. Measured by survey, 1 item.
Measured: Day 8
Past 7 Days Cigarillo Use
The number of days in the past 7 days that a participant reported using cigarillos, range 0-7. Measured by survey, 1 item.
Measured: Day 8
Little Cigar and Cigarillos (LCCs) Susceptibility
The average susceptibility to little cigar and cigarillo (LCC) use measured with the average of 3 survey item scores. Question scoring is on a scale of 1 to 4, where 1 indicates high susceptibility and 4 indicates low susceptibility to LCCs.
Measured: Day 8
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use
The cognitive elaboration score is measured by survey with 1 item. Question scoring is on a scale of 1 to 6, where 1 indicates that the participant has low cognitive elaboration about the health risks of LCCs and 6 indicates that a participant has high cognitive elaboration about smoking LCCs.
Measured: Day 2
Warning Negative Affect/Worry
Warning negative affect/worry is measured by survey with 1 item. Question scoring is on a scale of 1 to 5, where 1 indicates low worry due to the warning and 5 indicates high worry due to the warning.
Measured: Day 2
Knowledge of Little Cigar and Cigarillo (LCC) Harms
Knowledge of LCC harms will be measured by 12 items the survey. Scores can range from 0 to 12 and indicate the number of questions out of 12 about LCC harms that participants answered correctly.
Measured: Day 8
Beliefs About Little Cigar and Cigarillo (LCC) Harms
The average score on beliefs about LCC harms measured with 10 items by survey, are an average of the responses to the 10 questions. Belief scoring is on a scale of 1 to 5, where 1 indicates strong disagreement with statements about the health harms of LCCs and 5 indicates strong agreement with the statements about the health harms of LCCs.
Measured: Day 8
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use
The cognitive elaboration score is measured by survey with 1 item. Question scoring is on a scale of 1 to 6, where 1 indicates that the participant has low cognitive elaboration about the health risks of LCCs and 6 indicates that a participant has high cognitive elaboration about smoking LCCs.
Measured: Day 3
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use
The cognitive elaboration score is measured by survey with 1 item. Question scoring is on a scale of 1 to 6, where 1 indicates that the participant has low cognitive elaboration about the health risks of LCCs and 6 indicates that a participant has high cognitive elaboration about smoking LCCs.
Measured: Day 4
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use
The cognitive elaboration score is measured by survey with 1 item. Question scoring is on a scale of 1 to 6, where 1 indicates that the participant has low cognitive elaboration about the health risks of LCCs and 6 indicates that a participant has high cognitive elaboration about smoking LCCs.
Measured: Day 5
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use
The cognitive elaboration score is measured by survey with 1 item. Question scoring is on a scale of 1 to 6, where 1 indicates that the participant has low cognitive elaboration about the health risks of LCCs and 6 indicates that a participant has high cognitive elaboration about smoking LCCs.
Measured: Day 6
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use
The cognitive elaboration score is measured by survey with 1 item. Question scoring is on a scale of 1 to 6, where 1 indicates that the participant has low cognitive elaboration about the health risks of LCCs and 6 indicates that a participant has high cognitive elaboration about smoking LCCs.
Measured: Day 7
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use
The cognitive elaboration score is measured by survey with 1 item. Question scoring is on a scale of 1 to 6, where 1 indicates that the participant has low cognitive elaboration about the health risks of LCCs and 6 indicates that a participant has high cognitive elaboration about smoking LCCs.
Measured: Day 8
Warning Negative Affect/Worry
Warning negative affect/worry is measured by survey with 1 item. Question scoring is on a scale of 1 to 5, where 1 indicates low worry due to the warning and 5 indicates high worry due to the warning.
Measured: Day 3
Warning Negative Affect/Worry
Warning negative affect/worry is measured by survey with 1 item. Question scoring is on a scale of 1 to 5, where 1 indicates low worry due to the warning and 5 indicates high worry due to the warning.
Measured: Day 4
Warning Negative Affect/Worry
Warning negative affect/worry is measured by survey with 1 item. Question scoring is on a scale of 1 to 5, where 1 indicates low worry due to the warning and 5 indicates high worry due to the warning.
Measured: Day 5
Warning Negative Affect/Worry
Warning negative affect/worry is measured by survey with 1 item. Question scoring is on a scale of 1 to 5, where 1 indicates low worry due to the warning and 5 indicates high worry due to the warning.
Measured: Day 6
Warning Negative Affect/Worry
Warning negative affect/worry is measured by survey with 1 item. Question scoring is on a scale of 1 to 5, where 1 indicates low worry due to the warning and 5 indicates high worry due to the warning.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start18 Jul 2024
- Primary completion25 Nov 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Little Cigars and Cigarillos (LCC) UseStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 928 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- Leah Ranney, PhD, MA, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413797
- Sponsor's protocol ID
- 23-2455
- Other IDs
- 5R01CA260822-03
- Status last verified
- Dec 2025
- First submitted
- 9 May 2024
- Last updated
- 24 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kowitt SD, Clark SA, Jetsupphasuk M, Jarman KL, Jebai R, Goldstein AO, Cornacchione Ross J, Ranney LM. Examining the influence of descriptors used to market unflavoured cigarillos: an experiment with a sample of youth and young adults from the USA. Tob Control. 2026 Jan 8:tc-2025-059806. doi: 10.1136/tc-2025-059806. Online ahead of print.
PubMed 41506908
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Little Cigar and Cigarillo Warnings to Prevent Adolescent Use
- ClinicalTrials.gov ID
- NCT06413797
- Acronym / sponsor ID
- 23-2455
- Conditions
- Little Cigars and Cigarillos (LCC) Use
- Keywords
- cigarette warnings, youth, smoke cigars, nicotine addiction, cancer prevention, Black or African American youth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 928 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Food and Drug Administration (FDA)
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 14 May 2024 (actual)
- Results
- Posted 24 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study explores the effect of the little cigars and cigarillos (LCC) warnings on youth who currently use, have ever used, or are susceptible to using LCCs. This study will inform the Food and Drug Administration (FDA) implementation of LCC warnings, which can reduce LCC use and lessen tobacco health disparities among youth.
Detailed description
Cigar use exposes youth to the addictive effects of nicotine during a critical developmental period and increases the risk of multiple cancers and premature death. Recent data indicate that cigars are the second most commonly used tobacco product by youth and that past 30-day cigar use is 7.6%, which translates into 1.1 million high school students. Of the three major types of cigars-large cigars, little cigars, and cigarillos-little cigars and cigarillos (LCCs) are the most commonly used in the US, particularly among younger people. LCC use also contributes to tobacco health disparities, as Black or African American youth use cigars more frequently than other youth. In 2016, the Food and Drug Administration (FDA) deemed LCCs subject to FDA regulation, requiring six rotating text-only warning statements to be on LCC packaging. Previous research has examined the effectiveness of LCC warnings in reducing youth willingness to use LCCs.
Research from studies of cigarette warnings suggests that effective LCC warnings should employ images that illustrate negative health effects associated with use and a larger warning label prominently displayed on the pack. Among youth, health warnings on cigarette packs that contain both text statements and images are more effective and engaging than text-only warnings. However, evidence for cigarette warning labels cannot adequately inform implementation of improved LCC warnings for three reasons: 1) there is no evidence on the effectiveness of the FDA-mandated text-only LCC warnings on behavioral intentions or other outcomes among youth 2)courts have ruled that effective tobacco warnings on one type of tobacco product cannot be used to justify warnings on other types of tobacco, and 3) LCC users have different demographic and consumption profiles than cigarette users include more Black/African Americans and use LCCs on fewer days per month.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FDA warnings + Image | Experimental | Behavioral: FDA warnings + ImageParticipants will receive FDA-proposed LCC warnings with images |
| FDA Warnings Text-Only Warnings | Experimental | Behavioral: FDA Warnings Text-OnlyParticipants will receive FDA-proposed text-only LCC warnings. |
| Surgeon General Text-Only Warnings | Active comparator | Behavioral: Surgeon General Text-Only WarningsParticipants will receive Surgeon General text-only LCC warnings. |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Members of the recruitment panel (we are partnering with a panel provider for the recruitment of all participants)
- Agree to provide their honest answers
- Susceptible to using LCCs, or have ever used little cigars and/or cigarillos, or currently use little cigar and/or cigarillos in the past 30 days
- Age 15 - 20 years old
- Currently living in US or US territory
Key exclusion criteria (2 listed)
- Not able to verify they are not a bot using Completely Automated Public Turing test to tell Computers and Humans Apart (CAPTCHA).
- Not able to answer a simple, random math question.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDA warnings + ImageFor six days (days 2-7) participants will be contacted and asked to complete a daily survey. As part of the survey, participants will view FDA-proposed LCC warnings with images at 30% size on a cigarillo package. Participants will be contacted each day to be invited to complete the survey for that day of the study protocol. | Behavioural | FDA warnings + Image |
| FDA Warnings Text-OnlyParticipants will receive messages including images in 30% size. | Behavioural | FDA Warnings Text-Only Warnings |
| Surgeon General Text-Only WarningsParticipants will receive messages including Surgeon General Text-only Warnings. | Behavioural | Surgeon General Text-Only Warnings |
Primary outcome
Willingness to Use Little Cigars Cigarillos (LCCs)
Time frame: Day 8
The average willingness to use score will be measured by the average of the responses to the 2 survey questions scores. Question Scoring is on a scale of 1 to 5, where 1 indicates low willingness to use LCCs, and 5 indicates a willingness to use LCCs score.
18 secondary outcomes
Past 7 Days Little Cigar Use
Time frame: Day 8
Past 7 Days Cigarillo Use
Time frame: Day 8
Little Cigar and Cigarillos (LCCs) Susceptibility
Time frame: Day 8
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use
Time frame: Day 2
Warning Negative Affect/Worry
Time frame: Day 2
Knowledge of Little Cigar and Cigarillo (LCC) Harms
Time frame: Day 8
Beliefs About Little Cigar and Cigarillo (LCC) Harms
Time frame: Day 8
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use
Time frame: Day 3
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use
Time frame: Day 4
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use
Time frame: Day 5
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use
Time frame: Day 6
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use
Time frame: Day 7
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use
Time frame: Day 8
Warning Negative Affect/Worry
Time frame: Day 3
Warning Negative Affect/Worry
Time frame: Day 4
Warning Negative Affect/Worry
Time frame: Day 5
Warning Negative Affect/Worry
Time frame: Day 6
Warning Negative Affect/Worry
Time frame: Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41506908Kowitt SD, Clark SA, Jetsupphasuk M, Jarman KL, Jebai R, Goldstein AO, Cornacchione Ross J, Ranney LM. Examining the influence of descriptors used to market unflavoured cigarillos: an experiment with a sample of youth and young adults from the USA. Tob Control. 2026 Jan 8:tc-2025-059806. doi: 10.1136/tc-2025-059806. Online ahead of print.
- Clinical trials at UNC LinebergerLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leah Ranney, PhD, MA principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDA warnings + Image, FDA Warnings Text-Only and Surgeon General Text-Only Warnings in people with Little Cigars and Cigarillos (LCC) Use, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Willingness to Use Little Cigars Cigarillos (LCCs) (time frame: Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06413797, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.